This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people. Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification. The study protocol will be explained to the eligible participant and informed written consent will be obtained. The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease.
The investigators will collect the participant characteristics (age, gender, smoking history, comorbid diseases including history of previous stroke, myocardial infarction, angina, hypertension, dyslipidemia, T2DM, risk of osteoporosis, and all medication lists) at the first visit. * Physiological parameters: 1. Body composition will be assessed by the Bioelectrical Impedance at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months). 2. Peripheral venous blood sample (15mL: clotted blood 9mL and EDTA blood 6 mL) and urinalysis will be collected from all participants at baseline and each follow-up visit (1-month, 2-months, 6-month, and 12 months). Blood samples will be immediately centrifuged and plasma/serum will be placed in a -80 Celsius freezer until analysis (glucose, HbA1C, insulin, albumin, creatinine, uric acid, lipid profile, liver function test, kidney function test, thyroid function test, and other biochemical). * Three questionnaires will be collected: 1\) Global physical activity questionnaire, sleep questionnaire, and satiety visual analog score questionnaire will be obtained at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months). * Nutritional status will be assessed by history, 24-hour dietary recall, 3days food record, and physical examinations at the first visit and at each follow-up visit (1 month, 2 months, 4 months, 6 months, 9 months, and 12 months). Regarding the descriptive statistical analysis, all the data will be tested for normality. Data will be presented as Mean ± standard deviation or Median (interquartile ranges) for continuous variables and frequency (%) for binary and categorical variables. The continuous variables will be compared by using Independent samples T-test or Analysis of variance (ANOVA) followed by multiple comparisons with the Bonferroni method. Test results of categorical variables will be evaluated by Chi-square or Fisher exact test as appropriate. Results will be deemed statistically significant at a P-value \< 0.05.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
123
The participant will consume food about/ within 8-hour per day
The participant will consume food about/ within 8-hour per day. They will be received a reward as money when achieve weight loss goal or/and success doing intermittent fasting 5 days/week
Advice about nutrition knowledge, healthy eating diet, diet prescription, and exercise
Mahidol University
Ratchathewi, Bangkok, Thailand
HOMR-IR (index)
Homeostatic Model Assessment for Insulin Resistance
Time frame: Change from Baseline HOMR-IR at 6 months and 12 months
Body mass index (kg/m^2)
Body weight and height will be combined to report BMI in kg/m\^2
Time frame: Change from Baseline Body mass index at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months
FBS (mg/dl)
Fasting blood glucose
Time frame: Change from Baseline FBS (mg/dl) at 1 month, 2 months, 6 months, and 12 months
HbA1C (%)
Average blood sugar levels over the past 3 months
Time frame: Change from Baseline HbA1C (%) at 1 month, 2 months, 6 months, and 12 months
Albumin (g/L)
a blood plasma protein synthesized in the liver
Time frame: Change from Baseline Albumin (g/L) at 1 month, 2 months, 6 months, and 12 months
Creatinine (mg/dL)
a waste product that comes from the normal wear and tear on muscles of the body
Time frame: Change from Baseline Creatinine (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Alanine transaminase (ALT) U/L
ALT is commonly measured clinically as part of liver function tests
Time frame: Change from Baseline Alanine transaminase (ALT) U/L at 1 month, 2 months, 6 months, and 12 months
Aspartate transaminase (AST) U/L
AST is commonly measured clinically as part of liver function tests
Time frame: Change from Baseline Aspartate transaminase (AST) U/L at 1 month, 2 months, 6 months, and 12 months
Uric acid (mg/dL)
Time frame: Change from Baseline Uric acid (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Total cholesterol (mg/dL)
Time frame: Change from Baseline Total cholesterol (mg/dL) at 1 month, 2 months, 6 months, and 12 months
HDL-C (mg/dL)
High-density lipoprotein cholesterol
Time frame: Change from Baseline HDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months
LDL-C (mg/dL)
Low-density lipoprotein cholesterol
Time frame: Change from Baseline LDL-C (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Triglycerides (mg/dL)
Time frame: Change from Baseline Triglycerides (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Blood Urea Nitrogen (BUN) (mg/dL)
Time frame: Change from Baseline Blood Urea Nitrogen (BUN) (mg/dL) at 1 month, 2 months, 6 months, and 12 months
Urine albumin-creatinine ratio (UACR) (mg/g)
Time frame: Change from Baseline Urine albumin-creatinine ratio (UACR) (mg/g) at 1 month, 2 months, 6 months, and 12 months
Energy from food (kilocalories)
Energy from food (kilocalories) assess by 24hour-dietary recall and 3days food record
Time frame: Change from Baseline Energy from food (kilocalories) at 1 month, 2 months, 4 months, 6 months, 9 months, and 12 months
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